Eyedration by Bruder Air-Activated Moist Heat Eye Mask, 10 Mask Pack

About the Product

A pack of 10 individually wrapped single use eye masks. Each mask heats itself when its package is opened and air reaches the contents, so no microwave, cord or power source is needed. The mask is placed over the closed eyelids and held by elastic loops that go over the ears. The heat is produced by iron powder, activated carbon, water, inorganic salt and vermiculite. The mask holds 104 degrees Fahrenheit for 8 to 12 minutes and stays warm for about 20 minutes. Each mask is used once and then discarded.

People buy these as single use warm masks for travel or for anywhere without a microwave, since each one heats itself as soon as the wrapper is opened. The mask is worn over the closed eyelids on its elastic ear loops for up to 20 minutes and then discarded. It holds 104 degrees Fahrenheit for 8 to 12 minutes.

Materials

• Iron powder and activated carbon The heat generating contents sealed inside the mask, which warm when air reaches them once the wrapper is opened.
• Water, inorganic salt and vermiculite The rest of the heat generating contents, alongside the iron powder and carbon.
• Elastic ear loops The loops pulled from the centre of the mask and worn over the ears to hold it on the closed eyelids.

What Is Included

• Ten individually wrapped Eyedration by Bruder air-activated moist heat eye masks, supplied in a pouch

Specifications

How to Use

1. Open the package. The mask begins heating when it is opened.
2. Pull out the elastic loops from the center.
3. Place the non-printed side on the closed eyelids and the elastic loops over the ears.
4. Relax for up to 20 minutes.
5. Discard the mask after use. It is single use only.

Warnings

• For external use only. Keep away from children.
• Single use only. Discard after use.
• Do not heat in a microwave or oven.
• Remove contact lenses before use.
• If using eyedrops, wait 15 minutes before wearing Eyedration.
• Do not use on infants or persons who cannot feel heat.
• Do not use if skin irritation is present.
• Discontinue use if there is discomfort, or if the mask is punctured or damaged.
• Do not use if the package is punctured or torn, or if contents are leaking.
• Harmful if swallowed. Keep out of the reach of children and animals.
• After treatment, you may experience blurry vision that will clear in a few minutes as your tear glands are releasing beneficial fluids.
• Follow your doctor's recommendation for use.

Storage

• Keep in a cool dry place.

Regulatory

This product is listed with the FDA by The Hilsinger Company Parent, LLC, 575 West Street, Suite 120, Mansfield, MA 02048, under FDA establishment registration number 1039131. That registration lists the proprietary names Bruder, MediBeads, Thermalon and Eyedration under product code IMA, device name "Pack, Heat, Moist", regulation number 21 CFR 890.5730, device class 1.

21 CFR 890.5730 classifies the device as Class I (general controls) and states that the device is exempt from the premarket notification procedures in subpart E of part 807, subject to the limitations in 21 CFR 890.9. There is therefore no 510(k) number for this product, and none is required. Nothing here should be read as a statement of FDA approval or clearance.